New-Onset Diabetes After Transplantation: Results From a Double-Blind Early Corticosteroid Withdrawal Trial
Pirsch JD, Henning AK, et al.American Journal of Transplantation 2015 Jul;15(7):1982-90
Aims
To analyse the frequency, timing of development and risk factors associated with New-onset diabetes (NODAT) after early corticosteroid withdrawal (CSWD) in kidney transplant recipients against eight definitions of NODAT.
Interventions
On posttransplant day (PTD) eight, patients were randomised to receive either placebo (CSWD group) or prednisone (chronic corticosteroids (CCS) group).
Participants
277 kidney transplant recipients who were not diabetic pretransplant
Outcomes
Primary outcomes measured were HbA1c, fasting blood glucose and the use of insulin and/or hypoglycemic agents. Secondary outcomes were patient survival, death-censored graft survival, rates of death and graft loss and graft survival.
Follow-up
5 years
CET Conclusions
The Astellas steroid withdrawal study was a well conducted double-blind randomised controlled trial, comparing early steroid withdrawal following renal transplantation with maintenance at a dose of 5mg/day, with blinding preserved to 5 years. This manuscript does not report much new, but provides some more detail regarding incidence of new-onset diabetes (NODAT) in the trial. Other than a lower insulin requirement in the withdrawal arm, there was limited difference between the arms with no difference in overall incidence of NODAT. These findings echo the retrospective analysis of our own systematic review of the topic, that suggested that large metabolic benefits from steroid withdrawal are only seen when withdrawing from doses larger than 5 mg/day (Transplantation. 2011; 92(11):e63-4).
Data analysis
Strict intention-to-treat analysis
Quality notes
Score based on Woodle ES, First MR, Pirsch J, et al. “A prospective, randomized, double-blind, placebo-controlled multicenter trial comparing early (7 day) corticosteroid cessation versus long-term, low-dose corticosteroid therapy.†Ann Surg 2008; 248: 564–577.
Trial registration
Clincaltrials.gov - NCT00650468